Plan to Recode Prenatal Vitamins Spurs Lawsuit

SAN FRANCISCO (CN) – Plans to re-code prescription prenatal vitamins as over-the-counter in a widely used medical database will deny millions of women access to supplements that help prevent devastating birth defects, a vitamin seller claims in federal court.

New Jersey-based vitamin supplier Exeltis USA sued First Databank in the Northern District of California on Thursday, claiming its arbitrary reclassification will lead Medicaid and private insurers to deny coverage of the essential supplements.

Based in St. Louis, Missouri, First Databank is known as “the gatekeeper” for prescription drug reimbursement because it manages the nation’s most popular drug-coding database, according to the lawsuit.

First Databank, a subsidiary of Hearst Communications founded in 1982, plans to start re-coding the vitamins as over-the-counter on Sept. 15, according to the complaint.

While some prenatal vitamins are sold over-the-counter, Exeltis says it is one of several companies that sells them by prescription only. This allows doctors to select supplements with the medically appropriate formula of vitamins and minerals that meets a particular patient’s needs, Exeltis claims.

“Even though neither the law nor the marketing of these products has changed, First Databank has decided suddenly to code prescription prenatal vitamins as ‘Non-Rx’ or ‘over-the-counter’ – all at the behest of a few First Databank customers (who are third-party payors) that want to save money,” the 23-page complaint states.

Millions of women, especially those on Medicaid, depend on access to these vitamins, which prevent birth defects like spina bifida and anencephaly – the latter of which can cause babies to be stillborn or survive only a few hours after birth.

Each year, about 3,000 U.S. babies are born with anencephaly or spina bifida, according to the U.S. Centers for Disease Control and Prevention. Spina bifida can cause bone deformities, learning disabilities, seizures, bowel and bladder problems, and muscle weakness in the legs that limits mobility.

The use of folic acid supplements during pregnancy helps prevent 1,300 babies from developing potentially fatal birth defects each year, according to CDC research cited in the complaint.

The U.S. Food and Drug Administration, U.S. Preventative Health Task Force and CDC recommend that pregnant women take folic acid supplements.

Exeltis says the decision to reclassify the prescription vitamins would especially affect low-income women on Medicaid, who likely will not be able to afford the out-of-pocket costs for those supplements.

“First Databank’s false and deceptive coding will cause devastating public health consequences,” the vitamin seller claims in its lawsuit.

Exeltis accuses First Databank of libel, violating the Lanham Act and unfair business laws.

The vitamin supplier seeks damages and an injunction to block First Databank from “falsely and misleadingly characterizing” its prescription vitamins as over-the-counter.

Exeltis is represented by Ryan Sandrock of Sidley Austin in San Francisco.

First Databank did not immediately respond to emails seeking comment Friday morning.